Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects

Escoles Universitaries Gimbernat30 enrolled

Overview

Clinical trial on the physical and psychological effects of Horse Assisted Rehabilitation after the treatment of cancer in children 4 to 18 years of age.

Randomized controlled open labelled trial. Duration: 6 months. Groups: Control Group (standard follow-up) and Intervention Group (one weekly rehabilitation session assisted by horse). Participants: 30 children, 4 to 18 years of age, after 6 months of the discharge of the cancer treatment with nervous system involvement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Child, Only Child Behavior Neurologic Gait Disorder Neurologic Complication

Interventions

Horse-Assisted RehabilitationOTHER

One hour weelky session of hippotherapy.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children between 4 and 18 years of age, who had suffered a cancer with affectation of the Central Nervous System * With or without motor, functional and / or cognitive deficits or neurological disorders due to their basic problem or be as a consequence of the therapeutic procedures, with any degree of disability * More than 6 months after receiving the discharge of oncology (chemotherapy or radiotherapy) Exclusion Criteria: * Immunodepression * Hypotonia with severe pelvic instability that does not allow seating on the horse safely * Weight greater than 80Kg. * Phobia to horses

Locations (2)

Hospital Universitari de Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Outcomes

Primary Outcomes

Self-Reported Quality Of Life Changes

Pediatric Quality of Life Inventory - Child-Self Report (PedsQL-C) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).

Time frame: Baseline and 25th week

Secondary Outcomes

Parent-Proxys Reported Quality Of Life Changes

Pediatric Quality of Life Inventory - Parent-Proxy Report (PedsQL-PC) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).

Time frame: Baseline and 25th week

General Health Status Changes

Barcelona General Health Status Questionnaire 2000 (sections: C, D, E, F, K, L, M; qualitative questionnaire, no total score).

Time frame: Baseline and 25th week

Anxiety Changes

State Trait Ansiety IInventory for children (STAI-CH) - norm-referenced scores (T scores and percentile ranks) for each one of the two subscales: Anxiety-Trait \& Anxiety-State (scores 0-60 in each subscale, higher = worse).

Time frame: Baseline and 25th week

Depression Changes

Childhood Depression Inventory (CDI), self report long version (28 items) to assess the presence and severity of depressive symptoms in children. Scores range from 0-56, with higher scores indicating higher levels of depression.

Data from ClinicalTrials.gov

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Time frame: Baseline and 25th week

Behavior Changes

Behavior Assessment System for Children - Parent Rating Scale (BASC-PRS), second version (BASC-2) - BASC-2 is parent-reported, well-established scale for externalizing/internalizing problem of children and adolescents. Scoring manual and software is provided by the assessment developers; norm-referenced scores (T scores and percentile ranks) are available in the score reports, as are interpretations of strengths and weaknesses and target behaviors for intervention (mean of 50 and standard deviation of 10; for the behavior problem scales, scores above 60 are considered problematic; for the adaptive scales, scores below 40 are considered problematic).

Time frame: Baseline and 25th week

Self-Reported Physical Function Changes

PedsQL-C (subscale Health and Activities: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

Time frame: Baseline and 25th week

Parents-Reported Physical Function Changes

PedsQL-PC (subscale Physical Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

Time frame: Baseline and 25th week

Self-Reported Emotional Function Changes

PedsQL-C (subscale Feelings: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

Time frame: Baseline and 25th week

Parent-Reported Emotional Function Changes

PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

Time frame: Baseline and 25th week

Self-Reported Sociability Function Changes

PedsQL-C (subscale Get Along with Others: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)

Time frame: Baseline and 25th week

Parent-Reported Sociability Function Changes

Time frame: Baseline and 25th week

Balance Changes

Pediatric Balance Scale (PBS: 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks; Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The highest score in PBS is 56, higher is better).

Time frame: Baseline, 6th, 12th and 25th week

Position Changes

Sitting Assessment Scale (Sitting Assessment Scale (SAS) is a standardized observational instrument designed for assessment of sitting in children with cerebral palsy (CP); the scale is composed of five items evaluating head, trunk and foot control and arm and hand function, where each item is assessed with a score from 1 to 4 (1 =none; 2=poor; 3=fair; 4=good) and each score (1,2,3,4) has specific decriptors of each item of the SAS).

Time frame: Baseline, 6th, 12th and 25th week

Proprioception-Coordination Changes

Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07: the DCDQ is a brief questionnaire designed to screen for coordination disorders in children, aged 5 to 15 years, and consists of 15 items grouped into three distinct factors (motor control during movement, fine motor and handwriting and general coordination; to reach scores, sum each column to compute the numbers onto the Score Sheet, and add all factor scores to compute a Total Score: 0-75, higher is better).

Time frame: Baseline and 25th week

Autonomous Neurvous System activation function Changes

Heart Rate Variability (HRV, low/high frequency (LH/FH) power ratio; modulation of heart rate variability assessed through analysis of data collected by HRV wireless monitorisation and PolarH7(R) thoracic band (medical device), following the American and European Cardiological Societies).

Time frame: Baseline, 6th, 12th and 25th week